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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name kit, identification, enterobacteriaceae
510(k) Number K092393
Device Name EK/P. AERUGINOSA PNA FISH
Original Applicant
ADVANDX, INC.
10a roessler road
woburn,  MA  01801
Original Contact paula e bulger
Regulation Number866.2660
Classification Product Code
JSS  
Subsequent Product Code
JSZ  
Date Received08/05/2009
Decision Date 09/01/2009
Decision substantially equivalent (SESE)
Regulation Medical Specialty Microbiology
510k Review Panel Microbiology
statement statement
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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